Regulatory Expert Senior

2 days ago


New Albany, Ohio, United States Amplifybio, LLC Full time
About the Job

As a Senior QA Compliance Specialist, you will play a critical role in ensuring the quality of our products and services, as well as ensuring compliance with relevant regulations.

Key Responsibilities:
  • Implement and manage systems for Quality Management, Quality Assurance, Data stewardship, and governance.
  • Maintain complaint and nonconformance processing through records and tracking systems, including FMEA, root-cause analysis and corrective actions.
  • Participate in drafting quality assurance agreements as required.
  • Analyze operational and delivery processes, and ensure that they comply with company standards, industry regulations, state/federal laws, and sets the standard for best practices.
  • Ensure product and facility compliance with AmplifyBio policies and procedures, US and Global Quality System Regulations including, but not limited to 21CFR11, 21CFR210, 21CFR211, and EudraLex Volume 4 Annex 1.
Requirements

To be successful in this role, you will need:

  • A Bachelor's degree or higher in a relevant scientific discipline or equivalent education and experience.
  • A minimum of 5+ years of experience within the Quality Unit in a GMP pharmaceutical environment.
  • Experience with deviation and CAPA management, ASQ Certified Pharmaceutical GMP Professional a strong plus.
  • Ability to work with minimal supervision.
  • Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
Benefits

We offer a comprehensive benefits package, including:

  • Health, Dental, and Vision insurance that starts on your first day.
  • Competitive Compensation Package.
  • UNLIMITED PTO policy.
  • Generous paid parental leave.
  • Wellness and Self-Care Programs.
  • 401(k) match.
  • Tuition Reimbursement.
  • EAP/work-life support system.


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